Read the First Edition of The Lens, a new magazine by LSI arrow-icon

Bernard Peperstraete, Acuamark Diagnostics - Novel Early Cancer Screening | LSI Europe '24

Find out how we’re unlocking frequent, recurring monitoring for early cancer signal as the new standard of primary care. Learn More: https://acuamarkdx.com/
Speakers
Bernard Peperstraete
Bernard Peperstraete
Cofounder & CEO, Acuamark Diagnostics

Bernard Peperstraete 00:02
Good morning, everybody. Thank you for the great attendance. It's like the room is filling up slowly. Acuamark Diagnostics is an early cancer detection company. Our company has, for the first time, optimized qPCR for early cancer detection signal detection. Of course, the name of the game is to detect cancer early, so that the biggest impact on stage one and stage two can be had. The markets that we are pursuing are large, but the first ones that we are targeting are with the CRC screening product and a CRC recurrence product. So the product is going to be blood-based. And so what we are doing is we are optimizing PCR. We have innovated the assays. We have rebuilt them from the ground up. We combine that with predictive machine learning models, and then we potentially, for some of the samples, added a digital PCR step to get further granularity on the methylation levels. The markers are based on methylations. And so we had to innovate the qPCR piece to do broader multiplexing up to level 40 markers. And then, of course, we focused on methylations, which is also something that qPCR was not able to do before. And so what we are getting at is really something that is, of course, improved relative to other approaches, improved in terms of detection, but also remains very scalable and very accurate. It is not dependent on elaborate workflows. And at the end of the day, what it all boils down to is really saving more lives at a fraction of the cost. The data that we've gotten, we started testing samples in mid-2023, so we are now up to 216 stage one to stage four samples. The results vary between the machine learning models. We've about 50 machine learning models. You know, the ranges that we see between them are 85% to 92% sensitivity at 95% to 97% specificity. The best models produce a 92% sensitivity at 97% specificity, and some of the models detected all of the stage ones and the stage twos. Of course, we're very excited about that. One of the key differentiators is that we will not have to exclude individuals at higher risk. And of course, one of my pet peeves is that as a company, we think we should deserve to be in the marketplace and eventually be profitable, so the products are very high margin, cost-benefit wise as well. This is not something you see very often. It's for a reason. It's because other approaches are just challenged in terms of cost benefits. But we think clinical utility is very important in order to get this broadly adopted and reimbursed. And so we took a look at colonoscopy, the gallery tests, Cologuard, Shield, etc. We didn't include Freedom because we don't have pricing on Freedom, but we think it's somewhere along the range of the Shield test. And so when it comes to cost per life saved, we really intend to be at a fraction of the cost of the others. This all eventually fits in a distributed strategy. So we are building kits in order to deploy this onto a broad installed instrumentation base around the world. And while you do see a clear distributed strategy there, really, we have a very strong focus on accelerating and a strong emphasis on IVD kit strategy so that we can do a record rollout and run in any clinical laboratory that has the right equipment. So this slide I'm going to skip. In terms of our launches, we are going first with CRC recurrence. It's a different panel than CRC screening. We are going with CRC screening as well. We should be ready by 2026 to do a very limited initial, let's call it testing launch, while we, at the same time, keep on developing the IVD kits. The IPO is scheduled for 2027 with a minimum amount of revenue. We have started a very large collection. Last year, the first patient in should be mid-October or end October this year. That's a 23,400 individual study collection across 20 cancers, and basically from there onwards, we will be adding separate cancers. These cancers will be launched in fast cadence after the IPO. Again, here's an illustrative graphic of how this could potentially look. But a big emphasis for us is not just cost-effectiveness, not just improved detection, not just scalability, cost-effectiveness, fast turnaround, etc., but it's also margins. And so when it comes to becoming a company that has momentum and sustain momentum, we strongly believe that margins should be part of the story. There are lots of older comparables in the marketplace, both on the M&A side, in the public area, and more specifically, when we get to CRC screening, of course, we're talking about Exact Sciences as an example. At the time we made the slide, Exact had an $11 billion market cap and was just taken over at that time by Natara, with a $15 billion market cap for recurrence. This is our team, a very small team, but very proud of them, and we are currently testing the waters and seeing what the response is for a larger Series B round. This Series B round is $125 million, and we aim to do two raises with it and fund the company to the point of one year beyond IPO. The ask for the Series B will be, of course, number one, to attract the best-in-class team in the diagnostics industry. We want to complete our study and conduct others. We want to build that IVD kit, build out a regulatory team, do the right preparatory steps for IPO, and then, of course, expand from where we are today, the commercial partnerships. And of course, the company will, along the way, get ready for M&A. So at the end of the day, what everything comes down to for us is really just having the largest possible social impact, whereby most lives are saved with a reliable test, but at a fraction of the cost and with unique positioning and high earnings potential. So thanks so much for your attention. Thank you.

LSI USA ‘25 is filling fast. Secure your spot today to join Medtech and Healthtech leaders.

March 17-21, 2025 Waldorf Astoria, Monarch Beach | Dana Point, CA Register arrow